Ultrasound (US)-Guided Versus Sham Ultrasound Corticosteroid (CS) Knee Injections
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01032720|
Recruitment Status : Terminated
First Posted : December 15, 2009
Last Update Posted : July 8, 2015
|Condition or disease||Intervention/treatment|
|Osteoarthritis||Procedure: Ultrasound Procedure: Sham ultrasound|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Ultrasound-guided Versus Sham Ultrasound Corticosteroid Knee Injections|
|Study Start Date :||January 2010|
|Primary Completion Date :||February 2012|
|Study Completion Date :||February 2012|
Experimental: Ultrasound-guided knee CS injection
Ultrasound will be used to image knee joint and guide needle for intra-articular knee CS injection.
Ultrasound will be used to image knee joint and guide needle for intra-articular corticosteroid injection.
Other Name: Sonosite
Sham Comparator: Sham Ultrasound knee CS injection
CS knee injection will be performed in the same method as the US-guided knee injection but the US machine will be turned off.
Procedure: Sham ultrasound
Knee CS injection will be performed in the same method as the US-guided injection except that the US machine will be turned off. Study patient will be unaware of whether US machine is on or off.
Other Name: Sonosite
- Compare the effectiveness of US-guided vs. sham US CS intra-articular knee injections as measured by a 10-point between groups difference in the Knee injury and Osteoarthritis Outcome score (KOOS). [ Time Frame: 4 weeks ]
- Compare the effectiveness of US-guided vs. sham US CS knee injections in reducing pain as measured by KOOS. [ Time Frame: 2, 6, and 8 weeks ]
- Compare the effectiveness of US-guided vs. sham US CS knee injections in improving self-reported lower extremity function. [ Time Frame: 2, 4, 6, and 8 weeks ]
- Compare the effectiveness of US-guided vs. sham US CS knee injections in reducing the proportion of patients experiencing knee pain. [ Time Frame: 2, 4, 6, and 8 weeks ]
- Compare the effectiveness of US-guided vs. sham US knee injections in reducing the use of co-therapies (acetaminophen, nonsteroidal anti-inflammatory drugs, and narcotics) [ Time Frame: 2, 4, 6, and 8 weeks ]
- Examine whether body mass index, presence or absence of chronic widespread pain, radiographic severity, patient expectations, patient satisfaction, and dispositional optimism predict response to CS injections. [ Time Frame: 2, 4, 6, and 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032720
|United States, Connecticut|
|West Haven Veteran's Administration Medical Center|
|West Haven, Connecticut, United States, 06516|
|Principal Investigator:||Liana Fraenkel, M.D.||VACHS; Yale University School of Medicine|